Validation of ICG-99mTc-nanoscan as Hybrid Tracer for Sentinel Node Biopsy

Launched by THE NETHERLANDS CANCER INSTITUTE · Oct 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging agent called ICG-99mTc-nanoscan, which is used during a procedure known as sentinel node biopsy. This procedure helps doctors find out if cancer has spread to the lymph nodes in patients with certain types of cancer, including penile cancer, melanoma, and oral cancer. The trial aims to confirm that ICG-99mTc-nanoscan works similarly to the previously used agent, 99mTc-nanocolloid, in tracking lymphatic drainage patterns.

To participate in this trial, patients need to be over 18 years old and scheduled for a sentinel node biopsy. Eligible participants include those with specific types of skin or oral cancers or penile cancer who do not show signs of cancer spreading to the lymph nodes. Patients will receive the new imaging agent as part of their routine care, and they will be monitored to see how effectively it works. It’s important to note that individuals who are pregnant, have certain allergies, or have kidney issues may not be able to participate. If you or a loved one are considering joining this trial, you will be given detailed information about the process and what to expect.

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Eligibility criteria

• Inclusion Criteria:
• • Patient who will undergo a sentinel node procedure in routine care.
• • Patients \> 18 years;
• * Patients presenting with:
• • a primary cutaneous melanoma of head/neck or upper part of the trunk or extremities;
• • OR patients presenting with a primary oral cavity malignancy T1-2N0
• • OR patients with primary penile cancer
• • Patients with clinical N0 stage;
• • Patients scheduled for a sentinel node biopsy prior to (re-)excision of the primary lesion;
• • Patients in which ICG-99mTc-nanoscan would be used in routine care or a research setting
• Exclusion Criteria:
• • Patients with known allergy to patent blue dye or nanocolloid;
• • Patients who are pregnant or breast-feeding mothers;
• • History of hypersensitivity reactions to products containing human serum albumin;
• • History of iodine allergy
• • Hyperthyroid or thyroidal adenoma
• • Kidney insufficiency
• • Incapacity or unwillingness of participant to give written informed consent;